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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bit, drill
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTW
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2427
Fracture 273
Material Twisted / Bent 266
Dull, Blunt 229
Material Fragmentation 224
Bent 219
Device-Device Incompatibility 101
Device Operates Differently Than Expected 85
Entrapment of Device 73
Appropriate Term/Code Not Available 63
Failure to Cut 57
Corroded 40
Naturally Worn 37
Failure to Align 33
Material Deformation 31
Insufficient Information 31
Mechanical Jam 24
Adverse Event Without Identified Device or Use Problem 23
Use of Device Problem 22
Crack 22
Device Markings / Labelling Problem 18
Physical Resistance / Sticking 16
Delivered as Unsterile Product 16
Component Missing 16
Mechanical Problem 15
Packaging Problem 13
Tip 12
Separation Failure 12
Unintended Movement 10
Device Contamination with Chemical or Other Material 9
Incorrect Measurement 9
Difficult to Remove 9
Device Handling Problem 7
Manufacturing, Packaging or Shipping Problem 6
Fitting Problem 6
Defective Device 6
Connection Problem 5
Tear, Rip or Hole in Device Packaging 5
Difficult to Insert 5
Loss of or Failure to Bond 5
Temperature Problem 5
Scratched Material 4
Material Integrity Problem 4
Detachment of Device or device Component 4
Loose or Intermittent Connection 4
Residue After Decontamination 4
Device Issue 4
Contamination / decontamination Problem 4
Metal Shedding Debris 4
Improper or Incorrect Procedure or Method 3
Unraveled Material 3
Product Quality Problem 3
Pin 3
Detachment Of Device Component 3
Degraded 3
Material Erosion 3
Device Packaging Compromised 3
Mechanics Altered 3
Device Contaminated during manufacture or shipping 3
Device Difficult to Maintain 3
No Apparent Adverse Event 2
Patient Device Interaction Problem 2
Device Operational Issue 2
Flaked 2
Difficult or Delayed Positioning 2
Overheating of Device 2
Screw 2
Sticking 2
Device Inoperable 2
Deformation Due to Compressive Stress 2
Failure to Disconnect 2
Cut In Material 1
Activation, Positioning or Separation Problem 1
Device Or Device Fragments Location Unknown 1
Patient-Device Incompatibility 1
Battery Problem 1
Unstable 1
Material Separation 1
Inadequacy of Device Shape and/or Size 1
Device Slipped 1
Smoking 1
Vibration 1
Incomplete or Missing Packaging 1
Device Contamination with Body Fluid 1
Misassembled 1
Misconnection 1
Labelling, Instructions for Use or Training Problem 1
Kinked 1
Optical Decentration 1
Unsealed Device Packaging 1
Peeled / Delaminated 1
Difficult To Position 1
Device Difficult to Setup or Prepare 1
Off-Label Use 1
Unable to Obtain Readings 1
Unintended Collision 1
Positioning Failure 1
Disassembly 1
Material Frayed 1
Component Falling 1
Total Device Problems 4601

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag III Dec-22-2019
2 Biomet, Inc. II May-26-2016
3 Cayenne Medical Inc. II Jul-28-2018
4 MicroAire Surgical Instruments, LLC II Jan-26-2018
5 Synthes (USA) Products LLC II May-23-2016
6 Synthes, Inc. II Jun-04-2015
7 Tornier, Inc II May-09-2018
8 Trilliant Surgical Ltd. II Aug-24-2015
9 Zimmer GmbH II May-23-2019

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